Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: MEDTRONIC HALL PROSTHETIC HEART VALVES (MODELS A7700 AND M7700)
• Classification Name: heart-valve, mechanical
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P790018
• Supplement Number: S044
• Date Received: 08/29/2003
• Decision Date: 09/23/2003
• Product Code: LWQ [ Registered Establishments with LWQ ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Elimination of the production pulse duplication test from the manufacturing process.